Condition category
Mental and Behavioural Disorders
Date applied
24/02/2006
Date assigned
09/06/2006
Last edited
09/06/2006
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Joop de Jong

ORCID ID

Contact details

c/o HealthNet TPO
Tolstraat 127
Amsterdam
1074 VJ
Netherlands
+31 (0)20 6200005
jdejong@healthnettpo.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

A psychosocial school-based program is capable of reducing conflict-related psychosocial symptoms, and increasing children's strength to deal with armed-conflict related psychosocial difficulties

Ethics approval

Ongoing at ethical review board of Vrije Universiteit Amsterdam as of 09/06/06

Study design

Cluster randomization of schools to intervention (structured school-based psychosocial program) or waitlist condition (receiving treatment after the research)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Multiple impact of armed conflict on psychosocial wellbeing (post-traumatic stress disorder)

Intervention

Classroom-based structured, manualized psychosocial intervention, called the class-room based intervention (CBI), as designed by the Center for Trauma Psychology (Boston, Massachusetts) versus the waitlist condition.
The CBI entails a 15-session program that encompasses working with the trauma narrative, creative techniques (drama, music), and specifically designed games. The waitlist condition simply entails the provision of treatment after the research is finished.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Post-traumatic stress disorder (PTSD) and depressive symptoms

Secondary outcome measures

Anxiety, aggression, daily functioning, social support, sociometric measurements (sociogram), coping, family functioning, hope, and school functioning (grades, absenteeism)

Overall trial start date

01/07/2006

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Children screened for exposure to traumatic events, post-traumatic stress symptoms or depressive anxiety symptoms, with the use of symptom checklists

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

120 per treatment arm; total 240 children

Participant exclusion criteria

Serious psychopathology and psychiatric disorders (mutism, retardation, psychotic symptoms) or incapability to function in a group (conduct disorders, harming others), as judged by local psychosocial counsellors

Recruitment start date

01/07/2006

Recruitment end date

31/03/2007

Locations

Countries of recruitment

Sri Lanka

Trial participating centre

c/o HealthNet TPO
Amsterdam
1074 VJ
Netherlands

Sponsor information

Organisation

HealthNet TPO (The Netherlands)

Sponsor details

Tolstraat 127
Amsterdam
1074 VJ
Netherlands
+31 (0)20 6200005
jdejong@healthnettpo.org

Sponsor type

Charity

Website

http://www.healthnettpo.org

Funders

Funder type

Charity

Funder name

Plan International

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes